Generic Drugs’ Safety Labeling Often Incorrect

By Staff

1/23/2013

US Pharm. 2013;38(1):7.

Indianapolis, IN—Although generic drugs are required to carry
warnings identical to those on corresponding brand-name medications, a
study by the Regenstrief Institute has found that more than two-thirds
of generics have labeling discrepancies. Investigators reviewed more
than 9,100 product labels for more than 1,500 drugs available on
DailyMed, an online repository of labeling information maintained by the
FDA and the National Library of Medicine. Sixty-eight of 1,040 drugs
with more than one manufacturer’s label had discrepancies in safety
information. Most generics showed fairly small differences across
labels, but 9% of them had differences of more than 10 side effects.
Errors included out-of-date information, incomplete data, and (in one
case) information for an entirely different drug.

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